Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
试验速览
- 阶段
- 4 期
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- 1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.
研究概览
简要总结
We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.
详细描述
This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 6 and 59 months of age seen at the assessment centre during the study period
- •With fever defined as axillary temperature ≥37.5 °C or history of fever in the past 24 h
- •With a microscopically confirmed monoinfection of Plasmodium falciparum
- •Able to tolerate oral therapy,
- •Whose parents/guardians have provided written informed consent.
排除标准
- •Children with a history of allergy to quinine, artemether-Lumefantrine or milk.
- •Evidence of severe malaria.
- •Residence at more than 20km from the health clinic.
- •Evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness
研究组 & 干预措施
1.Oral quinine
Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days
干预措施: Oral quinine (Drug)
2. Coartem
Tablets
干预措施: artemether-lumefantrine (Drug)
结局指标
主要结局
1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.
时间窗: 28 days
次要结局
- 1. Fever clearance time assessed by self report. 2. Hemoglobin changes on day 0, 7, 14 and 28. 3. Safety profiles. 4. Adherence: measured by patient report and pill count on day 3 for the artemether-Lumefantrine group and day 7 for the quinine group.(28 days)